BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3082619 · Received April 23, 2013

    Report

    Report Number
    2027969-2013-00329
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ALERE SAN DEIGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER ISSUE, CUSTOMER ALWAYS TAKES OVER 15 SECONDS TO APPLY SAMPLE AND MILKS FINGER. ON THE (B)(6) 2013 COMPARISON, CUSTOMER USED THE SAME FINGERSTICK SITE. THESE TECHNIQUE ISSUES MAY CONTRIBUTE TO UNEXPECTED INR RESULTS OR ERRORS IN TESTING. PT CHANGED DOSAGE ON (B)(6) 2013 AFTER INRATIO RESULT WAS OBTAINED. THIS CHANGE IN MEDICATION CANNOT BE RULED OUT AS A CAUSE FOR THE UNEXPECTED RESULT. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2013, INRATIO METER = 1.0, REFERENCE = 5.0, MEAN = 3.45; CONFIDENCE LIMITS = 2.0 - 5.0. DATE: (B)(6) 2013, INRATIO METER = 1.5, REFERENCE = 2.7, MEAN = 2.10; CONFIDENCE LIMITS = 1-3 - 2.7. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR A, THE INRATIO REFERENCE VALUES FALL OUTSIDE THE LIMITS, SO THE CRITERIAL ARE NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIP ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. IN-HOUSE THERAPEUTIC DONOR TESTING PERFORMED ON REPORTED LOT 294799 ON (B)(4) 2013. RESULTS AS FOLLOWS: DONOR (B)(6): INRATIO: 3.8, 3.8, 3.4, REFERENCE: 3.38, BIAS THRESHOLD: 2.38 - 4.38; %CV: 6.30. DONOR (B)(6): INRATIO: 2.4, 2.5, 2.6, REFERENCE: 2.62, BIAS THRESHOLD: 1.62 - 3.62; %CV: 4.00. ALL REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. BOTH DONORS PRODUCED %CV LESS THAN 16%. PRECISION CRITERIA HAD BEEN MET. NO FURTHER INVESTIGATION IS NECESSARY. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT THE TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED SO RETAIN PRODUCTS WERE USED FOR INVESTIGATION TESTING. RETAIN STRIP TESTING RESULTS MET ACCURACY AND PRECISION CRITERIA. IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD OF >0.07%, CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH LAB. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2013, INRATIO: 1.0; LAB: 5.9. DATE: (B)(6) 2013, INRATIO: 1.5; LAB: 2.7. THERAPEUTIC RANGE: 2.5-3.5. TIME: 2-3 HOURS BETWEEN TESTS. AFTER THE READING ON (B)(6) 2013, THE PT TOOK 2.5 MG MORE THAN THE PRESCRIBED DOSE. THE PT MADE THIS DOSE ADJUSTMENT THEMSELVES, NO UNDER THE DIRECTION OF A PHYSICIAN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174769 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DEIGO, INC. 100071 294977

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MUCINEX| AUGMENTIN| EAR DROPS| COUMADIN| TYLENOL